Repaglinide tablet and preparation method thereof

A technology for repaglinide tablets and tablets, applied in the field of pharmaceutical manufacturing, can solve problems such as adverse reactions, and achieve the effects of improving solubility and improving curative effect

Inactive Publication Date: 2012-10-24
NANJING ZENKOM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] 4. Adverse reactions
In foreign countries, polacrilin potassium and repaglinide are used for compatibility, and the complexation between polacrilin potassium and repaglinide molecules is used to increase the s

Method used

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  • Repaglinide tablet and preparation method thereof
  • Repaglinide tablet and preparation method thereof
  • Repaglinide tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0025] Example 1:

[0026] prescription:

[0027]

[0028] Preparation method: Mix repaglinide, ethyl oleate, polyoxyethylene hydrogenated castor oil and polydiethanol 4000 evenly, heat to 60°C and stir to dissolve into a solution, add starch, stir evenly, dry at 60°C for 2 hours, pulverize Pass 80 mesh sieves, as intermediate (1) standby; Weigh the microcrystalline cellulose of recipe quantity and mix well with intermediate (1), dry 20 mesh granulation, 18 mesh granulation, add the cross-linked carboxylate of recipe quantity Sodium methylcellulose and magnesium stearate are mixed uniformly and compressed into tablets with a hardness of 5-8kg.

Example Embodiment

[0029] Example 2:

[0030] prescription:

[0031]

[0032] Preparation method: Mix repaglinide, ethyl oleate, polyethylene glycol 15 hydroxystearate, meglumine, and polydiethanol 6000 evenly, heat to 60°C and stir to dissolve into a solution, add calcium hydrogen phosphate, Stir well, dry at 60°C for 2 hours, pulverize through an 80-mesh sieve, and use as intermediate (1) for subsequent use; take the recipe amount of microcrystalline cellulose and mix well with intermediate (1), dry 20-mesh granulation, 18-mesh Entire granules, add sodium carboxymethyl starch and magnesium stearate in recipe quantities, mix well, and press into tablets with a hardness of 5-8kg.

Example Embodiment

[0033] Example 3: The dissolution test and long-term stability of the repaglinide tablets prepared in Example 1 and Example 2 and the commercially available repaglinide tablets (Novolone) were carried out.

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Abstract

The invention discloses a repaglinide tablet and a preparation method thereof, belonging to the new technical field of medicines. The repaglinide tablet mainly contains repaglinide and is prepared by a solid self-emulsifying technology, wherein the tablet further contains a diluent, an emulsifier, an assistant emulsifier, an adsorbent, filler, a disintegrating agent and a lubricant. The repaglinide tablet overcomes the instability of repaglinide, has the advantages of improved dissolution rate of repaglinide and enhanced treatment effect and has ideal treatment effect.

Description

technical field [0001] The invention belongs to the field of pharmaceutical manufacturing, and relates to a new technology of repaglinide, in particular to a repaglinide tablet and a preparation method thereof. Background technique [0002] Repaglinide is a non-sulfonylurea hypoglycemic drug, which was first developed by Boehringer Ingelheim and authorized to Novo Nordisk in 1990. 1997 Approved by the FDA for the treatment of type 2 diabetes [0003] 1. Pharmacology and Toxicology [0004] This product specifically binds to the 36KDA protein on the ATP-dependent potassium ion channel outside the islet β cell membrane, closes the potassium channel, depolarizes the β cell, opens the calcium channel, and promotes the influx of calcium ions to promote insulin secretion. ureides, so the postprandial hypoglycemic effect is faster. [0005] 2. Pharmacokinetics [0006] Repaglinide tablets are rapidly absorbed through the gastrointestinal tract, leading to a rapid increase in pl...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/451A61P3/10
Inventor 徐卓业
Owner NANJING ZENKOM PHARMA
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